FDA Approves Diabetes Drug Tirzepatide for Chronic Weight Management

FDA has approved another diabetes drug as a treatment for chronic weight management. Tirzepatide has been approved for weight loss in adults with a body mass index of 27 kg/m² or greater who also have a weight-related medical condition, such as hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease.

Eli Lilly will market tirzepatide as a weight loss drug under the name Zepbound. Tirzepatide is already approved to treat adults with type 2 diabetes under the name Mounjaro. This is the second diabetes drug that has been approved for a weight loss indication, following the approval of Wegovy (semaglutide; sold as Ozempic to treat type 2 diabetes) in June 2021.

"Obesity is a chronic disease that can result in serious health complications, including heart disease, stroke, and diabetes. Despite our knowledge of obesity as a treatable, chronic disease, people living with obesity still face many challenges in their health and weight management journey," Joe Nadglowski, president and CEO of the Obesity Action Coalition, said in a statement.² "New treatment options bring hope to the many people with obesity who struggle with this disease and are seeking better options for weight management."

Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that is administered once weekly via injection. The approval was based on the phase 3 SURMOUNT-1 and SURMOUNT-2 trials.

SURMOUNT-1 results were published in 2022 in New England Journal of Medicine³ and adults with obesity had average weight reductions of 19.5% on the 10-mg dose and 20.9% on the 15-mg dose by week 72. In comparison, patients on placebo had a weight reduction of 3.1%.

“This is an unusually substantial degree of weight reduction in response to an antiobesity medication as compared with findings reported in other phase 3 clinical trials,” the authors wrote. “Given that tirzepatide is both a GIP receptor and GLP-1 receptor agonist, we speculate that there may be additive benefit in targeting multiple endogenous nutrient-stimulated hormone pathways that have been implicated in energy homeostasis.”

In SURMOUNT-2, which was published June 2023 in The Lancet,⁴ participants had reductions in mean body weight up to 14.7%. For patients on the 15-mg dose, up to 65% of participants had reductions of 10% or more and 31% had reductions of 20% or more by week 72.

Common adverse events include nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection-site reactions, fatigue, hypersensitivity reactions, burping, hair loss, and gastroesophageal reflux disease.

“Unfortunately, despite scientific evidence to the contrary, obesity is often seen as a lifestyle choice—something that people should manage themselves,” said Leonard Glass, MD, senior vice president of global medical affairs, Lilly Diabetes and Obesity.² “For decades, diet and exercise have been a go-to, but it's not uncommon for a person to have tried 20-30 times to lose weight with this approach. Research now shows that the body may respond to a calorie-deficit diet by increasing hunger and reducing feelings of fullness, making weight loss more difficult.”

Wegovy costs about $1349 a month without insurance,⁵ and most private insurance companies and the federal health programs do not cover it.⁶ With insurance, Ozempic can cost as little as $25 for a monthly supply, but without insurance it can cost approximately $935 per month.⁷ At its list price of $1059.87, Zepbound will cost approximately 20% less than Wegovy 2.5 mg. Zepbound will be available in 6 doses—2.5, 5, 7.5, 10, 12.5, and 15 mg.

References

1. FDA approves new medication for chronic weight management. News release. News release. FDA. November 8, 2023. Accessed November 8, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-management

2. FDA approves Lilly's Zepbound (tirzepatide) for chronic weight management, a powerful new option for the treatment of obesity or overweight with weight-related medical problems. News release. Lilly. November 8, 2023. Accessed Novenber 8, 2023. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-zepboundtm-tirzepatide-chronic-weight

3. Jastreboff AM, Aronee LJ, Ahmad NN, et al; for the SURMOUNT-1 investigators. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387(3):205-216. doi:10.1056/NEJMoa2206038

4. Garvey WT, Frias JP, Jastreboff AM, et al; for the SURMOUNT-2 investigators. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2023;402(10402):613-626. doi:10.1016/S0140-6736(23)01200-X

5. What is the list price of Wegovy and will it impact me? NovoCare. Accessed November 8, 2023. https://www.novocare.com/obesity/products/wegovy/let-us-help/explaining-list-price.html

6. Tu L. Should insurance cover Wegovy, Ozempic and other new weight loss drugs? Scientific American. October 16, 2023. Accessed November 8, 2023. https://www.scientificamerican.com/article/should-insurance-cover-wegovy-ozempic-and-other-new-weight-loss-drugs/

7. Find out the cost of Ozempic. NovoCare. Accessed November 8, 2023. https://www.novocare.com/diabetes/products/ozempic/explaining-list-price.html